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Risk Based Design Control Requirements and Industry Best Practices for Medical Devices
- Reasons for design control.
- When design control begins.
- Elements of a design control program.
- How risk management fits into design control.
- Change control.
- Understanding validation consists of more than testing.
- Design History File.
Overview of the webinar
This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and within budget.
The important and confusing question of when, in a development process, Design Control begins will be answered. The differences between pre release and post release change control will be explained. The Design History File will be explained and a contents checklist discussed. The interrelationship between ongoing risk analysis and the design process will be explained. The new Human Factors requirements will be discussed.
Who should attend?
- Engineering personnel.
- Software developers.
- Development Engineers.
- Production Management.
- QA/ QC personnel.
- Management.
Why should you attend?
Designing a medical device and testing it to prove it works is not sufficient in the eyes of the FDA to provide a safe product for users. The FDA has determined, through analysis of product recall data, that the majority of recalls were due to a faulty design process, not faulty manufacturing. These recalled products were tested before release and later failed in unanticipated ways that were not considered in the design and testing process. FDA also concluded that a well controlled design process with risk analysis, change control, design reviews, hardware/ software validation and feedback of the risk analysis results into the design process will greatly reduce chances of an unsafe product.
Handouts are pre release change control form, post release change control form, user requirements template, DHF checklist.
Faculty - Mr.Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.